MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC STAR; EXCIMER LASER

Model Number 0030-1479

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The system was evaluated by a field service engineer.The field service found the photodiode had fallen out of the housing.The photodiode was replaced in housing for mirror optic no.2.The beam was aligned and calibrated.All modes of operation and calibrations were verified and no failures.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The surgery center reported that a patient was having a photorefractive keratectomy procedure.After the patient was prepared, the excimer gave a cover stuck error message.The surgery center was advised to set fluence and/or run a self-test.When they attempted to use the excimer the shutter was stuck and the surgeon could not complete the excimer portion of this procedure.The patient was sent home and is returning to the site in 3 weeks for follow up to determine next step.It will take weeks for the epithelium to grow back and patients vision is always poor until the epithelium grows back.

Manufacturer Narrative

In initial report, the manufacturer date provided was incorrect as it should have indicate the year 1999 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: STAR
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 7509633
• MDR Text Key: 108091146
• Report Number: 3006695864-2018-01048
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00(01)(21)3432
• UDI-Public: (01)(21)3432
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0030-1479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention